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Efficacy and Safety of Orally Administered DS107 in Adult Patients With Moderate to Severe Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03817190
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
DS Biopharma

Brief Summary:

The objective of this study is to compare the efficacy and safety of orally administered DS107 (2g) versus placebo in the treatment of moderate to severe Atopic Dermatitis (AD).

Oral DS107/Placebo capsules will be administered for 16 weeks. The study will enrol approximately 200 subjects.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: DS107 Drug: Placebo Phase 2

Detailed Description:

This study involves a comparison of 2g DS107 with placebo, administered orally once daily for a total of 16 weeks. Patient will be randomized to one of the two treatment arms in a 1:1 ratio.

Patients will come to the clinic on 12 occasions: at Screening/Visit 1, Baseline/Visit 2, Week 2/Visit 3, Week 4/Visit 4, Week 6/Visit 5, Week 8/Visit 6, Week 10/Visit 7, Week 12/Visit 8, Week 14/ Visit 9, Week 16/Visit 10 (end of treatment), Week 18/ Visit 11 (follow up) and Week 20/Visit 12 (follow-up).

The primary endpoint will be the vIGA (Validated Investigator's Global Assessment) and EASI (Eczema Area and Severity Index). Other endpoints include vIGA, EASI, BSA (Body Surface Area) and NRS (Numeric Rating Scale).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Study to Assess the Efficacy and Safety of Orally Administered DS107 in Adult Patients With Moderate to Severe Atopic Dermatitis
Actual Study Start Date : September 19, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: 2g Oral DS107
2g DS107 (4 DS107 capsules) administered once-daily for 16 weeks
Drug: DS107
DS107 Capsule

Placebo Comparator: Placebo
Placebo (4 placebo capsules) orally administered once-daily for 16 weeks
Drug: Placebo
Placebo capsule




Primary Outcome Measures :
  1. Validated Investigator Global Assessment (vIGA) [ Time Frame: 16 Weeks ]
    Proportion of patients achieving a vIGA score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points.

  2. Eczema Area Severity Index (EASI) [ Time Frame: 16 Weeks ]
    Proportion achieving EASI-75


Secondary Outcome Measures :
  1. Validated Investigator Global Assessment (vIGA) [ Time Frame: 20 Weeks ]
    Proportion of patients achieving a vIGA score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points.

  2. Eczema Area Severity Index (EASI) [ Time Frame: 20 Weeks ]
    Proportion achieving EASI-75

  3. Numeric Rating Scale (NRS) [ Time Frame: 20 Weeks ]
    Proportion achieving a decrease of at least 4 points

  4. Body Surface Area [ Time Frame: Week 20 ]
    change from baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a clinically confirmed diagnosis of active AD according to the American Academy of Dermatology Consensus Criteria.
  • Patients with moderate to severe AD at baseline as defined by a vIGA score of 3 or 4 at baseline.
  • Patients with an EASI score of ≥16 at screening and baseline.
  • Patients with AD covering a minimum 10% of the body surface area at baseline.

Exclusion Criteria:

  • Patients with other skin conditions that might interfere with AD diagnosis and/or evaluation (such as psoriasis or current active viral, bacterial and fungal skin infections)
  • Patients who have used systemic treatments that could affect AD less than 4 weeks prior to baseline visit (Day 0). Intranasal corticosteroids and inhaled corticosteroids for stable medical conditions are allowed.
  • Patients who have used any topical medicated treatment for AD two weeks prior to start of treatment/ Baseline (Day 0).
  • Patients who have had excessive sun exposure, have used tanning booths or other ultraviolet (UV) light sources four weeks prior to Baseline (Day 0) and/or are planning a trip to a sunny climate or to use tanning booths or other UV sources between screening and follow-up visits.
  • Patients who have a white cell count or differential white cell count (neutrophils, lymphocytes, eosinophils) outside of the normal reference range at screening.
  • Patients who have a clinically significant impairment of renal or hepatic function.
  • Patients who are pregnant, planning pregnancy, breastfeeding and/or are unwilling to use adequate contraception (as specified in inclusion criterion 10) during the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817190


Contacts
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Contact: Kirsty Kelly 0035312933591 k.kelly@dsbiopharma.com
Contact: Moayed Hamza m.hamza@dsbiopharma.com

Locations
Show Show 25 study locations
Sponsors and Collaborators
DS Biopharma
Investigators
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Study Chair: Markus Weissbach, MD DS Biopharma
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Responsible Party: DS Biopharma
ClinicalTrials.gov Identifier: NCT03817190    
Other Study ID Numbers: DS107G-05-AD3
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases